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Annalise Enterprise is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the following findings:

• · acute subdural/epidural hematoma*
  · acute subarachnoid hemorrhage *

· intra-axial hemorrhage*

· intraventricular hemorrhage*

*These findings are intended to be used together as one device.

The device analyzes studies using an artificial intelligence algorithm to identify findings. It makes study-level output available to an order and imaging management system for worklist prioritization or triage.

The device is not intended to direct attention to specific portions of an image and only provides notification for suspected findings.

Its results are not intended:

· to be used on a standalone basis for clinical decision making

· to rule out specific findings, or otherwise preclude clinical assessment of CTB studies

Intended modality:

Annalise Enterprise identifies suspected findings in non-contrast brain CT studies.

Intended user:

The device is intended to be used by trained clinicians who, as part of their scope of practice, are qualified to interpret brain CT studies.

Intended patient population:

The intended population is patients who are 22 years or older.

Annalise Enterprise CTB Triage Trauma is a software workflow tool which uses an artificial intelligence (Al) algorithm to identify suspected findings on non-contrast brain CT studies in the medical care environment. The findings identified by the device include acute subdural/ epidural hematoma, acute subarachnoid hemorrhage, intra-axial hemorrhage, and intraventricular hemorrhage.

Radiological findings are identified by the device using an AI algorithm - a convolutional neural network trained using deep-learning techniques. Images used to train the algorithm were sourced from datasets that included a range of equipment manufacturers including Toshiba, GE Medical Systems, Siemens, Philips, and Canon Medical Systems. This dataset, which contained over 200,000 CT brain imaging studies, was labelled by trained radiologists regarding the presence of the four findings of interest.

The performance of the device's AI algorithm was validated in a standalone performance evaluation, in which the case-level output from the device was compared with a reference standard ('ground truth'). This was determined by two ground truthers, with a third truther used in the event of disagreement. All truthers were US board-certified neuroradiologists.

The device interfaces with image and order management systems (such as PACS/RIS) to obtain noncontrast brain CT studies for processing by the AI algorithm. Following processing, if any of the clinical findings of interest are identified in a non-contrast brain CT study, the device provides a notification to the image and order management system for prioritization of that study in the worklist. This enables users to review the studies containing features suggestive of these clinical findings earlier than in the standard clinical workflow. It is important to note that the device will never decrease a study's existing priority in the worklist. This ensures that worklist items will never have their priorities downgraded based on AI results.

The device workflow is performed parallel to and in conjunction with the standard clinical workflow for interpretation of non-contrast brain CTs. The device is intended to aid in prioritization and triage of radiological medical images only.

Here is a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The results for sensitivity and specificity above were presented across different operating points and slice thickness ranges, demonstrating the device's performance for each specific finding. The submission states that these results demonstrate the device establishes effective triage based on high sensitivity and specificity and are "substantially equivalent to those of the predicate device."

Specific acceptance criteria are not explicitly defined as pass/fail thresholds in the provided text. Instead, the reported performance metrics (sensitivity, specificity, and turn-around time) are presented as proof of meeting the requirements for 'Radiological computer aided triage and notification software' and supporting substantial equivalence.

Study Information

1. Sample sizes used for the test set and the data provenance:

   • Standalone Performance Evaluation (retrospective):
     • Total cases: 1,485 cases for slice thickness ≤1.5mm (1,003 positive, 482 negative) and 1,878 cases for slice thickness >1.5mm (1,257 positive, 621 negative).
     • Provenance: Collected consecutively from five US hospital network sites. The test dataset was newly acquired and independent from the training dataset.
   • Triage Effectiveness Study (internal bench study):
     • Total cases: 277 cases positive for any of the findings eligible for prioritization.
     • Provenance: Collected from multiple data sources spanning a variety of geographical locations, patient demographics, and technical characteristics.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: At least two neuroradiologists, with a third used in case of disagreement.
   • Qualifications: US board-certified neuroradiologists, ABR-certified, and protocol-trained.

3. Adjudication method for the test set:

   • Consensus determined by two ground truthers, and a third ground truther in the event of disagreement (2+1 adjudication). The cases were annotated in a blinded fashion.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • A multi-reader multi-case (MRMC) comparative effectiveness study was not specifically described in the provided text. The performance assessment focused on standalone performance and triage effectiveness (turn-around time).

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance evaluation was done. The case-level output from the device's AI algorithm was compared directly with the reference standard (ground truth).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Expert Consensus: The ground truth was determined by the consensus of multiple ABR-certified and protocol-trained neuroradiologists.

7. The sample size for the training set:

   • "Over 200,000 CT brain imaging studies."

8. How the ground truth for the training set was established:

   • The training dataset, containing over 200,000 CT brain imaging studies, "was labelled by trained radiologists regarding the presence of the four findings of interest."

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